NDAORALCAPSULE
Approved
May 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROMETRIUM (progesterone) by Fresenius Kabi is clinical pharmacology prometrium capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1998.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMETRIUM is an oral micronized progesterone capsule that is chemically identical to progesterone of ovarian origin. It is indicated for use in hormone replacement therapy and endometrial protection in postmenopausal women. The drug works by providing exogenous progesterone, which increases serum concentrations in a dose-proportional manner with peak levels achieved within 1.5–2.3 hours of oral administration.
LOE Approaching
Product approaching loss of exclusivity with limited recent commercial expansion; smaller brand teams may be consolidating resources.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration of…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.